The National Institute of Neurological Disorders and Stroke (NINDS) has stopped enrollment in a clinical trial that is evaluating whether intracranial angioplasty combined with stenting adds benefit to aggressive medical therapy alone for preventing stroke in patients with symptomatic intracranial arterial stenosis. The study was the first prospective randomized multicenter trial to compare aggressive medical management alone versus aggressive medical management plus angioplasty combined with stenting in patients with symptomatic highgrade stenosis of a major intracranial artery. Recruitment began in November of 2008 and was halted on April 5, 2011 after 451 (59%) of the planned 764 patients had been enrolled at 50 participating sites in the US.

At the time of the most recent DSMB review, 14% of patients treated with angioplasty combined with stenting experienced a stroke or died within the first 30 days after enrollment compared with 5.8% of patients treated with medical therapy alone, a highly significant difference. The SAMMPRIS Executive Committee is in agreement with NINDS and the DSMB that enrollment in the study should be stopped and that the trial data currently available indicate that aggressive medical management alone is superior to angioplasty combined with stenting in patients with recent symptoms and high grade intracranial arterial stenosis. All are indebted to the patients who contributed to this important study.

Read the entire clinical alert at http://www.nlm.nih.gov/databases/alerts/intracranial_arterial_stenosis.html

NIH’s Office of Extramural Research has a new web site that provides information to help NIH applicants and grantees (recipients of extramural grants and cooperative agreements)  understand their roles and responsibilities in relation to ClinicalTrials.gov and the Food and Drug Administration Amendments Act (FDAAA) of 2007.  The information on this site may not apply to NIH contracts or NIH intramural research.

This site includes:

• an overview of FDAAA and its relationship to certain trials funded through NIH grants and cooperative agreements;
• an overview of registration and results reporting requirements;
• instructions for providing the NIH with certification of compliance with FDAAA; and
• FAQs for NIH grantees, definitions and acronyms, and other resources.

The site is available at: http://grants.nih.gov/ClinicalTrials_fdaaa/index.htm.